Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Mercury MedicalLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Mercury Enterprises, Inc. with 3 510(k) clearances and 3 device recalls. The most recent is a device recall dated Dec 10, 2024: Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 10508Class I · Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause | Device recalls |
| Aug 30, 2024 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.Class I · Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Device recalls |
| Oct 22, 2015 | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator Class II · Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure t | Device recalls |
| Mar 30, 1989 | GENNY DENNY IV SHIELDK885342 · FMK | 510(k) clearances |
| Aug 10, 1987 | INTECARE PEDIATRIC URINE COLLECTORK871789 · FFH | 510(k) clearances |
| Aug 11, 1986 | TUBING CONNECTOR #10-810-60 100/PKG NON-STERILEK862722 · FKY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
